T/CACM 1379-2022 Active

Scope: This document defines the terms and definitions in the process of preparing traditional Chinese medicine injections by ultrafiltration, and stipulates the selection of ultrafiltration membranes, the requirements for the properties of fluids before ultrafiltration, the selection of ultrafiltration process parameters, the determination of ultrafiltration effect, and the cleaning and maintenance of ultrafiltration membranes. This document is applicable to scientific research institutions, pharmaceutical production and R&D enterprises, and equipment manufacturing companies that use ultrafiltration technology to remove high-molecular substances, pyrogens, bacterial endotoxins, and microparticles in traditional Chinese medicine injections that may pose safety risks to the product. Main technical content: Foreword III Introduction IV 1. Scope 2. Normative referenced documents 3. Terms and definitions 4. Selection of ultrafiltration membranes 34.1. Material selection 34.2. Confirmation of molecular weight cutoff 34.3. Dissolution test 34.4. Compatibility 44.5. Standard water flux determination 44.6. Integrity test 5. Requirements for the properties of fluids before ultrafiltration 55.1. Molecular weight distribution 55.2. Clarity 55.3. Viscosity 55.4. pH value 55.5. Temperature 6. Selection of ultrafiltration process parameters 6.1. Key parameters of the ultrafiltration process 6.2. Fluid pretreatment 6.3. Molecular weight cutoff 6.4. Flow rate parameters 6.5. Viscosity range 6.6. Temperature range 7. Determination of ultrafiltration effect 7.1. Solution clarity 7.2. Solution color 7.3. Protein 7.4. Resin 7.5. Tannins 7.6. High-molecular substances 7.7. Bacterial endotoxins 7.8. Pyrogens 7.9. Main component content 7.10. Fingerprint map 8. Cleaning and maintenance of ultrafiltration membranes 8.1. Cleaning and maintenance methods 8.2. Cleaning operation steps 8.3. Confirmation of clea